Ranbaxy Laboratories Limited (RLL) has received final approval from the US Food and Drug Administration to manufacture and market cetirizine hydrochloride tablets, 5 mg and 10 mg.
The office of generic drugs, US Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug zyrtec allergy tablets, 5mg and l0mg and zyrtec hives relief tablets, 5mg and 10mg by Pfizer Pharmaceuticals Inc. Total annual market sales for cetirizine hydrochloride tablets as a prescription only product were $1.3 billion (IMS - MAT: September 2007).
Cetirizine hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
"We are pleased to receive this final approval for cetirizine hydrochloride tablets (OTC) 5mg and 10mg that have proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions. This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, vice president of sales and distribution for Ohm Laboratories Inc, a wholly owned subsidiary of RLL.
Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.